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NIH Single IRB of Record Requirement

Please find information below related to the NIH single IRB of Record requirement. Contact CPHS with questions. 

NIH funded research: Applications submitted on or after January 25, 2018 for multi-site non-exempt research involving human subjects for new or competing renewals must describe the use of a single IRB.

In general, the prime awardee organization will provide IRB review for the entire project (all sites). The application must identify the IRB of Record (which is subject to the approval of the funding agency). If the Dartmouth CPHS is the proposed IRB of Record, please contact the CPHS early on in the proposal development phase. If you are developing or a receiving a subcontract for a NIH funded new study or submitting a competing renewal of a multi-site study involving human subjects please contact CPHS for a discussion including:

  • Is Dartmouth the lead site (site receiving NIH funding)?
  • Will Dartmouth be a site on a proposal being subitted by another institution?
  • Has the IRB of Record been determined?
  • Fee structure
  • Dartmouth responsibilities

IRB Reliance Agreements do not need to be in place at the time of application however IRB Reliance Agreements must be in place prior to the initiation of human subject research at each site. The IRB Reliance Agreement will describe the role of each site. IRB Reliance Agreements are managed by the Office of the Committee for the Protection of Human Subjects (CPHS) at Dartmouth. 

 

Additional information: The NIH single IRB Policy * From the NIH Office of Science Policy

When does the single IRB policy take effect?

The sIRB policy applies to applications received on or after January 25, 2018

Why is NIH promoting the use of a single IRB for multi-site research studies?

The use of a single IRB of record for multi-site studies conducting the same protocol will help streamline the IRB review process and remove redundant hurdles to the initiation of such studies. The policy will allow research to proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.

What types of studies are expected to use a single IRB under the new NIH policy?

The NIH single IRB policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. The NIH single IRB policy does not apply to studies conducted under career development, research training or fellowship awards. Under the policy, "multi-site" is defined as two or more sites. Foreign sites participating in NIH funded, multi-site studies will not be expected to follow this policy. The policy recognizes that it may not always be possible to use a single IRB, and it provides for exceptions (see Exceptions FAQ's below).

What are options for awardees to comply with the NIH single IRB policy?

An NIH awardee has several possible options for complying with the NIH single IRB policy including having the IRB at one of the participating sites agree to serve as the single IRB, using an independent IRB, or using the IRB as required in the Funding Opportunity Implementation of the sIRB policy NIH Office of Science Policy Announcement (FOA) or Request for Proposal (RFP) (for example, certain cancer clinical trials funded by the National Cancer Institute (NCI) are required to use the NCI Central IRB (CIRB)). As required in the federal Protection of Human Subjects regulations (45 CFR 46), the IRB must be registered with the Office for Human Research Protections (OHRP) and must have the appropriate membership, including the professional competence necessary to review the proposed research.

Where can I find more information on the NIH single IRB policy?

The policy was published in the NIH Guide to Grants and Contracts (NOT-OD-16-094) and the Federal Register (81 FR 40325) on June 21, 2016. More information about this policy may be found on the Office of Science Policy (OSP) website (http://osp.od.nih.gov/clinical-research/irb-review/). NIH will continue to provide additional resources and guidance to this policy prior to the implementation date. Additionally, questions about the NIH single IRB policy may be sent to: SingleIRBPolicy@mail.nih.gov

Posted: September 2017

 

 

 

Last Updated: 9/15/17